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GTx Presents Preclinical Studies of GTx-758, a Selective Estrogen Receptor Alpha Agonist for First Line Treatment of Advanced P

^{Published on 2010-11-15 04:10:41 - Market Wire}
 

ATLANTA--([ BUSINESS WIRE ])--GTx, Inc. (Nasdaq: GTXI) announced the presentation of preclinical studies evaluating GTx-758, a selective estrogen receptor alpha agonist being developed for first line treatment of advanced prostate cancer, and GTx-230, a novel microtubule polymerization inhibitor.

"Oral administration of GTx-758 reduces serum testosterone but does not increase whole blood platelet aggregation in mature male cynomolgus monkeys."

The study results were presented this past weekend in Atlanta at the annual meeting of the Society of Basic Urologic Research (SBUR).

GTx-758: An oral selective estrogen receptor alpha agonist, GTx-758 is being developed for first line treatment in men with advanced prostate cancer. In a Phase II open label pharmacokinetic/pharmacodynamic (PK/PD) clinical trial in 60 healthy young male volunteers, treatment with 1000 mg and 1500 mg doses of GTx-758 demonstrated the ability to achieve medical castration (serum total testosterone < 50 ng/dL). In the first half of 2011, GTx is planning to initiate a Phase II clinical trial evaluating GTx-758 compared to Lupron® (leuprolide acetate) for first line treatment of advanced prostate cancer.

GTx presented results of three preclinical GTx-758 studies at the SBUR:

• aImproved bone quality and suppression of testosterone levels by a novel selective estrogen receptor alpha agonist.a
  Lead author: Kearbey, Jeffrey

• aOral administration of GTx-758 reduces serum testosterone but does not increase whole blood platelet aggregation in mature male cynomolgus monkeys.a
  Lead author: Veverka, Karen

• aAnti-prostate effects of a selective estrogen receptor- agonist, GTx-758, in vitro and in aged male cynomolgus monkeys.a
  Lead author: Narayanan, Ramesh

GTx-230: An orally available tubulin antagonist discovered by GTx researchers, GTx-230 has the potential to treat cancer and cancer refractory to taxane and vinca alkaloid therapy. Unlike currently approved therapies, GTx-230 binds to tubulin at the colchicine site and circumvents multidrug resistance transporters resulting in potent suppression of cancer and taxane-resistant tumor xenografts. Importantly, in animal models GTx-230 also has less neurotoxicity than currently approved therapies.

GTx presented results of a preclinical GTx-230 study at the SBUR:

• aPotent antitumor activity and pharamcokinetics of a novel microtubule polymerization inhibitor in xenograft models of multidrug resistant tumors.a
  Lead author: Ahn, Sunjoo

About GTx

GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways for the treatment and prevention of cancer, the treatment of side effects of anticancer therapy, cancer supportive care, and other serious medical conditions.

Forward-Looking Information is Subject to Risk and Uncertainty

This press release contains forward-looking statements based upon GTxa™s current expectations. Forward-looking statements include, but are not limited to and statements relating to GTxa™s plans to initiate clinical trials for GTx-758, statements related to the therapeutic potential of GTxa™s product candidates. Forward-looking statements involve risks and uncertainties. GTxa™s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials planned to be conducted by GTx, Ipsen, or any potential future collaborators may not be initiated or completed on schedule, or at all, or may otherwise be suspended or terminated; (iv) that GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTxa™s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on November 9, 2010, contains under the heading, aRisk Factorsa, a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.